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Recruiting NCT06792981

Evaluation of a Digital School-Based Intervention for the Primary Prevention of Eating Disorders in Pre-Adolescents (PRETA Program)

Trial Parameters

Condition Eating Disorders in Adolescence
Sponsor Servicio Canario de Salud
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,068
Sex ALL
Min Age 10 Years
Max Age 13 Years
Start Date 2025-03-10
Completion 2025-12-31
Interventions
Universal primary prevention program based on ICTs

Brief Summary

Background: Eating Disorders (ED) are mental health conditions, characterized by pathological behaviors toward food intake or a persistent obsession with weight control. EDs have a high prevalence among pre-adolescents in developed countries and pose a significant economic burden. Preventive interventions targeting at-risk populations for ED have proven effective. The use of Information and Communication Technologies (ICTs) facilitates access to larger population groups while also reducing costs. Objectives: * Develop and validate a universally applied intervention (PRETA), mediated by ICTs, to reduce eating-disorder risk and modifiable risk factors, through cultural adaptation and adjustment of the POtsdam Prevention at Schools (POPS) Program to preadolescents. * Assess the efficacy of the PRETA Program through a randomized controlled trial (RCT). * Evaluate the efficiency of the PRETA Program from a social perspective. Methodology The PRETA Program uses 9 online sessions with interactive activities for pre- adolescents, plus education for their families and teachers. Its content includes addressing key factors in the development of ED, such as eating habits, beauty standards, and media literacy, as well as activities aimed at strengthening psychological dimensions (self-esteem, emotional regulation, problem-solving, psychological flexibility, and resilience) and social skills, including communication styles and distinguishing between jokes and bullying. The study involves schools being randomly assigned to either the PRETA Program or regular health activities. The effect of the intervention will be evaluated 3 months after its start.

Eligibility Criteria

Inclusion Criteria: * Enrolled in the fifth or sixth year of primary education. * Informed consent provided by the student's legal guardians and responsible teacher to participate. Exclusion Criteria: * Significant comprehension difficulties that limit adequate participation in the program and questionnaires.

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